Regulatory Affairs Specialist

18 Jul, 2021

Jobs

Regulatory Affairs Specialist

CoaguSense Inc.
Fremont, CA

SUMMARY

This position is a member of the CoaguSense Regulatory team with the responsibility of supporting and assisting in domestic and international regulatory submissions, registrations and product updates for CoaguSense products. This team member will also be involved with the planning and implementation of IVDR requirements for international approval of products.

ESSENTIAL DUTIES AND RESPONSIBILITIES

  • Work closely and under the direct supervision of the Manager, Regulatory Affairs to develop and maintain regulatory processes and SOPs to ensure compliance with the latest applicable domestic and international regulatory requirements;
  • Assist in the compilation, preparation, and review of domestic and international regulatory submissions to authorities;
  • Keep abreast of new, proposed or revised domestic and international regulations with the ability to determine the impact to the company and products;
  • Assist in the implementation of compliance requirements for IVDR, including revision to internal procedures, preparation for clinical trials and Post Market Surveillance;
  • Prepare and/or review analytical and clinical protocols to assure collection of appropriate data for regulatory submissions;
  • Participate in risk management activities including revisions to current procedures and files according to the latest standard;
  • Anticipate regulatory obstacles and emerging issues throughout the product lifecycle and develop solutions with other members of regulatory and related teams.

QUALIFICATIONS  

  • Must have a working understanding and knowledge of both U.S. and international regulations, including FDA Quality System Regulations (21 CFR Part 820), ISO 13485 Medical devices — Quality Management Systems, In Vitro Diagnostic Directive (98/79/EC) and all relevant domestic and international standards as outlined in the company’s Quality Manual.
  • Demonstrated ability to perform detail oriented work with a high degree of accuracy and recall.  Requires strong written, oral, interpersonal, group, and communication skills. Effective organization and planning skills.
  • Must be able to follow established policies and procedures, revise or create new procedures, and comply with regulatory requirements.
  • Computer skills are required, with experience using Microsoft Office: Word, Excel, and PowerPoint.
  • Demonstrated ability to deal with unresolved situations, frequent changes, delays or unexpected events.
  • To perform this job successfully, an individual must be able to perform each essential duty satisfactorily.  The requirements listed above and below are representative of the knowledge, skill, and/or ability required.  Reasonable accommodations may be made to enable individuals with disabilities to perform the essential functions.

EDUCATION and/or EXPERIENCE

  • Prefer a Bachelor’s Degree in the natural or biological sciences, or equivalent.  Will consider years of work related experience in lieu of degree.
  • A minimum of 3 to 5 years of experience in the medical device industry, preferably with experience in IVD products.  Exposure to MDR and/or IVDR regulatory requirements a plus.

LANGUAGE SKILLS

  • The ability to communicate articulately, in English, both verbally and in written materials is required.

MATHEMATICAL SKILLS

  • The candidate must be able to perform basic math functions.

REASONING ABILITY

  • Ability to recognize problems, recommend and implement solutions. A logical and organized thought pattern is required.

WORK ENVIRONMENT 

  • The individual must work well in a rapid paced environment.   The position requires the candidate to be flexible, and have the ability to juggle many projects at a time.

Learn more here

Job posted: 2021-07-18